Qualification Execution Checklist

Equipment: Filter Integrity Tester

Subcategory: Prefilled Syringes & Cartridges

Area: Production/QC

DQ/IQ/OQ/PQ Flags: Yes/Yes/Yes/Yes

CSV Required: Yes

Pre-start

Training completed
SOPs reviewed
URS approved
RA approved

Calibration/PM Status Verification

Calibration status verified
PM completed

Protocol Readiness and Approvals

Protocol drafted
Protocol approved by Engineering
Protocol approved by Validation
Protocol approved by QA

Execution Controls

GDP followed
Data recorded accurately
Deviations documented

Review and Approvals

Engineering review completed
Validation review completed
QA review completed